Double-blind Placebo-controlled Multicenter Randomized Trial of Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Double blind, placebo controlled, multicenter randomized trial in pregnant women in the U.S. (N=300) to test the central hypothesis that IV iron in pregnant women with IDA (Hb\<11 g/dL and ferritin\<30 ng/mL) at 13 - 30 weeks will be effective, safe and cost-effective in reducing severe maternal morbidity-as measured by maternal anemia at delivery-and will also improve offspring neurodevelopment.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Pregnant women between the ages of 18-45
• Singleton gestation
• Iron-deficiency anemia (serum ferritin \<30ng/mL and Hb\<11 g/dL)
• At 13-30 weeks gestation
• Plan to deliver at participating hospital
Locations
United States
Alabama
University of Alabama Medical Center
RECRUITING
Birmingham
Florida
GNP Research at Heme-on-Call
RECRUITING
Miami
Michigan
Michigan University Medical Center
RECRUITING
Ann Arbor
Missouri
Washington University Medical Center
RECRUITING
St Louis
Oregon
Oregon Health and Sciences Uiversity Medical Center
RECRUITING
Portland
Rhode Island
Hasbro Children's Hospital
RECRUITING
Providence
Women & Infants Hospital of Rhode Island
RECRUITING
Providence
Utah
University of Utah Hospital
RECRUITING
Salt Lake City
Contact Information
Primary
Crystal Ware, BSN, CCRP
cware@wihri.org
401-274-1122
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 300
Treatments
Experimental: IV Iron
Participants assigned to the IV iron group will receive a single IV infusion of 1000 mg ferric derisomaltose (Monoferric, Pharmacosmos Therapeutics Inc., Morristown, NJ) in 250 mL given over 20 minutes and daily placebo tablets until delivery.
Active_comparator: Oral Iron
Participants assigned to the oral iron group will receive a single 250 mL IV normal saline infusion given over 20 minutes and 325mg tablets of ferrous sulfate (65 mg of elemental iron) to be taken until delivery.
Related Therapeutic Areas
Sponsors
Collaborators: Washington University School of Medicine, University of Michigan, Oregon Health and Science University, Hasbro Children's Hospital, University of Utah, University of Alabama at Birmingham, GNP Research at Heme-on-Call
Leads: Women and Infants Hospital of Rhode Island